- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01201759
Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)
Effects of Salsalate on Prandial-Induced Vascular Inflammation After SCI
The overall study objectives are to examine whether:
- Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and
- An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
To test Study Objective 1, 'overweight' and 'non-overweight' persons with SCI will be compared at baseline for fasting and postprandial responses. For Study Objective 2, all persons tested for Study Objective 1 will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. The last month will test effects of drug-placebo not examined in month 2. Fasting and postprandial responses will be tested at each time point. Intention-to-treat clinical standards ("…as randomized, so analyzed…") and 'last observation carried forward' clinical methods will be adopted.
Participants with tetraplegia are sought, as they have fewer exercise options than those with paraplegia and are at greater risk for sedentary lifestyle resulting in CVD, CVD risks, and obesity.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Florida
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Miami, Florida, Vereinigte Staaten, 33136
- The Miami Project to Cure Paralysis
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- SCI resulting in tetraplegia at C3-C7
- injury for more than one year
Exclusion Criteria:
- 1. any recent dietary or other lifestyle changes;
- 2. diabetes or inflammatory medical conditions;
- 3. a pressure ulcer;
- 4. lung or bladder infection;
- 5. undiagnosed illness or fever;
- 6. recent surgery;
- 7. stomach ulcer or a history of stomach upset when taking aspirin or medicines like aspirin, or ,
- 8. currently taking medicines used for pain or inflammation (aspirin and non-steroidal anti-inflammatory drugs, corticosteroids), blood vessel diseases (statins or fibric acid derivatives), blood clotting disorders (Coumadin, Plavix), infections (antibiotics), diabetes (Metformin), and burning 'central' pain (voltage regulators).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Placebo to Salsalate 2gr BID
Placebo twice a day for 30 days.
Then Salsalate 2gr BID for 30 days.
|
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo.
An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo.
An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2.
|
Experimental: Salsalate 2gr BID to placebo
Salsalate 2grams twice a day for 30 days.
Then Placebo for 30 days.
|
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo.
An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2
Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo.
An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow.
After the wash-in month participants will receive either Salsalate or the placebo.
The last month will test effects of drug-placebo not examined in month 2.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Zeitfenster: Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min. For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Zeitfenster: Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min. For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.
Zeitfenster: Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
|
The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min. For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject's factors. |
Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..
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Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5
Zeitfenster: Study visit at min -30 (fasting)
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The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting). For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject's factors. |
Study visit at min -30 (fasting)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mark S Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Wunden und Verletzungen
- Trauma, Nervensystem
- Erkrankungen des Rückenmarks
- Entzündung
- Verletzungen des Rückenmarks
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Antirheumatika
- Cyclooxygenase-Inhibitoren
- Salicylsalicylsäure
- Natriumsalicylat
Andere Studien-ID-Nummern
- 20090361
- TMP-MN-004 (Andere Kennung: Clinicaltrials.gov)
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